Home / Recalls / Medical Devices
AZIYO BIOLOGICS recalls BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioE
Recalled October 16, 2019 · FDA recall Z-0039-2020 · AZIYO BIOLOGICS
Hazard
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. · FDA Class II
Units
1018 units
Sold at
US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.
Description
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Product
BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.
Manufacturer(s)
AZIYO BIOLOGICS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →